Topical Oxygen Wound Therapy (MEDICAID)

Topical Oxygen Wound Therapy (MEDICAID) Last Review Date: September 11, 2015 Number: MG.MM.DM.15C6v2 Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, ( EmblemHealth ) has adopted the herein policy in providing management, administrative and other services to HIP Health Plan of New York, HIP Insurance Company of New York, Group Health Incorporated and GHI HMO Select, related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Definitions Topical oxygen wound therapy (TOWT) Pressure ulcer staging in this guideline is as follows Wound healing The controlled application of 100% oxygen directly to an open moist wound at slightly higher then atmospheric pressure. An oxygen concentrator is connected to a FDA approved O 2 boot and/or O 2 sacral device that are for onetime use and disposable, therefore reducing the risk of cross contamination. Defined as: 1. Stage I nonblanchable erythema of intact light toned skin or darker or violet hue in darkly pigmented skin. 2. Stage II partial thickness skin loss involving epidermis and/or dermis. 3. Stage III full thickness skin loss involving damage or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. 4. Stage IV full thickness skin loss with extensive destruction, tissue necrosis or damage to muscle, bone, or supporting structures. Defined as improvement occurring in either surface area or depth of the wound. Lack of improvement of a wound is defined as a lack of progress in these quantitative measurements. Guideline Medicaid/Family Health Plus members are eligible for coverage of topical oxygen wound therapy when criteria 1 and any of criteria 2 6 are met: 1. A complete wound therapy program as applicable, depending on the type of wound, has been attempted prior to application of TOWT, including: Documentation in the patient's medical record of evaluation, care, compliance and wound measurements by the treating physician, and Application of dressings to maintain a moist wound environment, and Debridement of necrotic tissue if present, and Evaluation of and provision for adequate nutritional status, and

of 8 2. Stage IV pressure ulcers: The patient has been appropriately turned and positioned, and The patient has used a support surface for pressure ulcers on the posterior trunk or pelvis (not required if the ulcer is not on the trunk or pelvis), and The patient's moisture and incontinence have been appropriately managed, or 3. Neuropathic (for example, diabetic) ulcers: The patient has been on a comprehensive diabetic management program, and Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities, or 4. Venous insufficiency ulcers: Compression bandages and/or garments have been consistently applied, and Leg elevation and ambulation have been encouraged, or 5. For non-healing surgically created or traumatic wounds, documentation of medical necessity for accelerated formation of granulated tissue as a result of which cannot be achieved by other topical wound treatments, or 6. A chronic (being present for at least 30 days) ulcer of mixed etiology. Limitations/Exclusions TOWT is considered investigational, not medically necessary, medically contraindicated and not covered for all other indications, including but not limited to, the following: 1. The presence in the wound of necrotic tissue with eschar, if debridement is not attempted. 2. Untreated osteomyelitis within the vicinity of the wound. 3. Cancer present in the wound. 4. The presence of a fistula to an organ or body cavity within the vicinity of the wound. 5. Stage I, II or III pressure ulcers. Documentation, Preauthorization and Coding Requirements Department regulations and policies regarding ordering and provision of DME are available at http://www.nyhealth.gov/nysdoh/phforum/nycrr18.htm and in the DME Provider Manual at www.emedny.org/providermanuals/dme/index.html. Specifically: 1. Payment for E1390 includes all necessary equipment, delivery, maintenance and repair costs, arts, supplies and services for equipment set-up, maintenance and replacement of worn essential accessories and parts. Payment for A4575 includes the dressing set and canister set used in conjunction with E1390 and contains all necessary components, including but not limited to an occlusive dressing which creates a seal around the wound site for maintaining the desired concentration of oxygen at the wound. Payment for E1390 and A4575 is considered payment in full for TOWT. 2. An initial electronic prior authorization (DVS) will be granted for A4575 for a maximum of 16 days in a 28 day period, as treatment is 4 days on, 3 days off. The provider should request authorization once for the number of days (units) based on the written order. Prior approval is required for treatment exceeding 4 weeks. E1390 is not prior authorized and is billed monthly. 3. TOWT should be attempted first in a hospital or another health care facility prior to discharge to the home setting. In these continuing cases, documentation should reflect patient compliance and pain management during application of TOWT. If TOWT has not been attempted, providers must obtain an

of 8 initial prior authorization of two weeks (8 days or units) only. Prior approval may then be requested for an extension of the treatment. 4. Documentation of previous treatment regimens and how the patient meets the coverage criteria above must be maintained in the patient s medical record and available upon request. This documentation must include dressing types and frequency of change, changes in wound conditions (including precise length, width and surface area measurements), quantity of exudates, presence of granulation and necrotic tissue, concurrent measures being addressed relevant to wound therapy (debridement, nutritional concerns, support surfaces in use, positioning, incontinence control, etc.) and training received by the patient/family in the application of the occlusive dressing to the wound site and proper hook up of the oxygen to the dressing set. 5. When an extension of treatment is requested, the following documentation must be submitted: how the patient meets the coverage criteria, status of wound healing, weekly quantitative measurements of wound characteristics, wound length, width and depth (surface area) and amount of wound exudate (drainage) and patient compliance with the treatment plan. If detailed documentation is insufficient or if any measurable degree of wound healing has failed to occur, prior approval beyond the initial approved period of service will not be granted. 6. Upon completion of treatment, documentation regarding the outcome of treatment with TOWT must be submitted to the Plan. 7. All services must be supported by the original, signed written order specific to the item being requested from a qualified licensed prescriber. 8. All providers are responsible for assuring that adequate and less costly alternatives for services have been explored and, where appropriate and cost effective, are provided. Applicable Procedure Codes A4575 E1390 Topical hyperbaric oxygen chamber, disposable Oxygen concentrator, single delivery port, capable of delivering 85 percent or greater oxygen concentration at the prescribed flow rate Applicable ICD-10 Diagnosis Codes E08.621 Diabetes mellitus due to underlying condition with foot ulcer E08.622 Diabetes mellitus due to underlying condition with other skin ulcer E08.628 Diabetes mellitus due to underlying condition with other skin complications E09.621 Drug or chemical induced diabetes mellitus with foot ulcer E09.622 Drug or chemical induced diabetes mellitus with other skin ulcer E09.628 Drug or chemical induced diabetes mellitus with other skin complications E10.621 Type 1 diabetes mellitus with foot ulcer E10.622 Type 1 diabetes mellitus with other skin ulcer E11.621 Type 2 diabetes mellitus with foot ulcer E11.622 Type 2 diabetes mellitus with other skin ulcer E13.621 Other specified diabetes mellitus with foot ulcer E13.622 Other specified diabetes mellitus with other skin ulcer I83.001 Varicose veins of unspecified lower extremity with ulcer of thigh I83.002 Varicose veins of unspecified lower extremity with ulcer of calf

of 8 I83.003 Varicose veins of unspecified lower extremity with ulcer of ankle I83.004 Varicose veins of unspecified lower extremity with ulcer of heel and midfoot I83.005 Varicose veins of unspecified lower extremity with ulcer other part of foot I83.008 Varicose veins of unspecified lower extremity with ulcer other part of lower leg I83.009 Varicose veins of unspecified lower extremity with ulcer of unspecified site I83.011 Varicose veins of right lower extremity with ulcer of thigh I83.012 Varicose veins of right lower extremity with ulcer of calf I83.013 Varicose veins of right lower extremity with ulcer of ankle I83.014 Varicose veins of right lower extremity with ulcer of heel and midfoot I83.015 Varicose veins of right lower extremity with ulcer other part of foot I83.018 Varicose veins of right lower extremity with ulcer other part of lower leg I83.019 Varicose veins of right lower extremity with ulcer of unspecified site I83.021 Varicose veins of left lower extremity with ulcer of thigh I83.022 Varicose veins of left lower extremity with ulcer of calf I83.023 Varicose veins of left lower extremity with ulcer of ankle I83.024 Varicose veins of left lower extremity with ulcer of heel and midfoot I83.025 Varicose veins of left lower extremity with ulcer other part of foot I83.028 Varicose veins of left lower extremity with ulcer other part of lower leg I83.029 Varicose veins of left lower extremity with ulcer of unspecified site I83.201 Varicose veins of unspecified lower extremity with both ulcer of thigh and inflammation I83.202 Varicose veins of unspecified lower extremity with both ulcer of calf and inflammation I83.203 Varicose veins of unspecified lower extremity with both ulcer of ankle and inflammation I83.204 Varicose veins of unspecified lower extremity with both ulcer of heel and midfoot and inflammation I83.205 Varicose veins of unspecified lower extremity with both ulcer other part of foot and inflammation I83.208 Varicose veins of unspecified lower extremity with both ulcer of other part of lower extremity and inflammation I83.209 Varicose veins of unspecified lower extremity with both ulcer of unspecified site and inflammation I83.211 Varicose veins of right lower extremity with both ulcer of thigh and inflammation I83.212 Varicose veins of right lower extremity with both ulcer of calf and inflammation I83.213 Varicose veins of right lower extremity with both ulcer of ankle and inflammation I83.214 Varicose veins of right lower extremity with both ulcer of heel and midfoot and inflammation I83.215 Varicose veins of right lower extremity with both ulcer other part of foot and inflammation I83.218 Varicose veins of right lower extremity with both ulcer of other part of lower extremity and inflammation I83.219 Varicose veins of right lower extremity with both ulcer of unspecified site and inflammation I83.221 Varicose veins of left lower extremity with both ulcer of thigh and inflammation I83.222 Varicose veins of left lower extremity with both ulcer of calf and inflammation I83.223 Varicose veins of left lower extremity with both ulcer of ankle and inflammation I83.224 Varicose veins of left lower extremity with both ulcer of heel and midfoot and inflammation I83.225 Varicose veins of left lower extremity with both ulcer other part of foot and inflammation I83.228 Varicose veins of left lower extremity with both ulcer of other part of lower extremity and inflammation I83.229 Varicose veins of left lower extremity with both ulcer of unspecified site and inflammation I87.011 Postthrombotic syndrome with ulcer of right lower extremity I87.012 Postthrombotic syndrome with ulcer of left lower extremity I87.013 Postthrombotic syndrome with ulcer of bilateral lower extremity I87.019 Postthrombotic syndrome with ulcer of unspecified lower extremity

of 8 I87.031 Postthrombotic syndrome with ulcer and inflammation of right lower extremity I87.032 Postthrombotic syndrome with ulcer and inflammation of left lower extremity I87.033 Postthrombotic syndrome with ulcer and inflammation of bilateral lower extremity I87.039 Postthrombotic syndrome with ulcer and inflammation of unspecified lower extremity I87.2 Venous insufficiency (chronic) (peripheral) I87.311 Chronic venous hypertension (idiopathic) with ulcer of right lower extremity I87.312 Chronic venous hypertension (idiopathic) with ulcer of left lower extremity I87.313 Chronic venous hypertension (idiopathic) with ulcer of bilateral lower extremity I87.319 Chronic venous hypertension (idiopathic) with ulcer of unspecified lower extremity I87.331 Chronic venous hypertension (idiopathic) with ulcer and inflammation of right lower extremity I87.332 Chronic venous hypertension (idiopathic) with ulcer and inflammation of left lower extremity I87.333 Chronic venous hypertension (idiopathic) with ulcer and inflammation of bilateral lower extremity I87.339 Chronic venous hypertension (idiopathic) with ulcer and inflammation of unspecified lower extremity L59.9 Disorder of the skin and subcutaneous tissue related to radiation, unspecified L89.004 Pressure ulcer of unspecified elbow, stage 4 L89.014 Pressure ulcer of right elbow, stage 4 L89.024 Pressure ulcer of left elbow, stage 4 L89.104 Pressure ulcer of unspecified part of back, stage 4 L89.114 Pressure ulcer of right upper back, stage 4 L89.124 Pressure ulcer of left upper back, stage 4 L89.134 Pressure ulcer of right lower back, stage 4 L89.144 Pressure ulcer of left lower back, stage 4 L89.154 Pressure ulcer of sacral region, stage 4 L89.204 Pressure ulcer of unspecified hip, stage 4 L89.214 Pressure ulcer of right hip, stage 4 L89.224 Pressure ulcer of left hip, stage 4 L89.304 Pressure ulcer of unspecified buttock, stage 4 L89.314 Pressure ulcer of right buttock, stage 4 L89.324 Pressure ulcer of left buttock, stage 4 L89.44 Pressure ulcer of contiguous site of back, buttock and hip, stage 4 L89.504 Pressure ulcer of unspecified ankle, stage 4 L89.514 Pressure ulcer of right ankle, stage 4 L89.524 Pressure ulcer of left ankle, stage 4 L89.604 Pressure ulcer of unspecified heel, stage 4 L89.614 Pressure ulcer of right heel, stage 4 L89.624 Pressure ulcer of left heel, stage 4 L89.814 Pressure ulcer of head, stage 4 L89.894 Pressure ulcer of other site, stage 4 L89.94 Pressure ulcer of unspecified site, stage 4 L97.101 Non-pressure chronic ulcer of unspecified thigh limited to breakdown of skin L97.102 Non-pressure chronic ulcer of unspecified thigh with fat layer exposed L97.103 Non-pressure chronic ulcer of unspecified thigh with necrosis of muscle L97.104 Non-pressure chronic ulcer of unspecified thigh with necrosis of bone L97.109 Non-pressure chronic ulcer of unspecified thigh with unspecified severity

of 8 L97.111 Non-pressure chronic ulcer of right thigh limited to breakdown of skin L97.112 Non-pressure chronic ulcer of right thigh with fat layer exposed L97.113 Non-pressure chronic ulcer of right thigh with necrosis of muscle L97.114 Non-pressure chronic ulcer of right thigh with necrosis of bone L97.119 Non-pressure chronic ulcer of right thigh with unspecified severity L97.121 Non-pressure chronic ulcer of left thigh limited to breakdown of skin L97.122 Non-pressure chronic ulcer of left thigh with fat layer exposed L97.123 Non-pressure chronic ulcer of left thigh with necrosis of muscle L97.124 Non-pressure chronic ulcer of left thigh with necrosis of bone L97.129 Non-pressure chronic ulcer of left thigh with unspecified severity L97.201 Non-pressure chronic ulcer of unspecified calf limited to breakdown of skin L97.202 Non-pressure chronic ulcer of unspecified calf with fat layer exposed L97.203 Non-pressure chronic ulcer of unspecified calf with necrosis of muscle L97.204 Non-pressure chronic ulcer of unspecified calf with necrosis of bone L97.209 Non-pressure chronic ulcer of unspecified calf with unspecified severity L97.211 Non-pressure chronic ulcer of right calf limited to breakdown of skin L97.212 Non-pressure chronic ulcer of right calf with fat layer exposed L97.213 Non-pressure chronic ulcer of right calf with necrosis of muscle L97.214 Non-pressure chronic ulcer of right calf with necrosis of bone L97.219 Non-pressure chronic ulcer of right calf with unspecified severity L97.221 Non-pressure chronic ulcer of left calf limited to breakdown of skin L97.222 Non-pressure chronic ulcer of left calf with fat layer exposed L97.223 Non-pressure chronic ulcer of left calf with necrosis of muscle L97.224 Non-pressure chronic ulcer of left calf with necrosis of bone L97.229 Non-pressure chronic ulcer of left calf with unspecified severity L97.301 Non-pressure chronic ulcer of unspecified ankle limited to breakdown of skin L97.302 Non-pressure chronic ulcer of unspecified ankle with fat layer exposed L97.303 Non-pressure chronic ulcer of unspecified ankle with necrosis of muscle L97.304 Non-pressure chronic ulcer of unspecified ankle with necrosis of bone L97.309 Non-pressure chronic ulcer of unspecified ankle with unspecified severity L97.311 Non-pressure chronic ulcer of right ankle limited to breakdown of skin L97.312 Non-pressure chronic ulcer of right ankle with fat layer exposed L97.313 Non-pressure chronic ulcer of right ankle with necrosis of muscle L97.314 Non-pressure chronic ulcer of right ankle with necrosis of bone L97.319 Non-pressure chronic ulcer of right ankle with unspecified severity L97.321 Non-pressure chronic ulcer of left ankle limited to breakdown of skin L97.322 Non-pressure chronic ulcer of left ankle with fat layer exposed L97.323 Non-pressure chronic ulcer of left ankle with necrosis of muscle L97.324 Non-pressure chronic ulcer of left ankle with necrosis of bone L97.329 Non-pressure chronic ulcer of left ankle with unspecified severity L97.401 Non-pressure chronic ulcer of unspecified heel and midfoot limited to breakdown of skin L97.402 Non-pressure chronic ulcer of unspecified heel and midfoot with fat layer exposed L97.403 Non-pressure chronic ulcer of unspecified heel and midfoot with necrosis of muscle L97.404 Non-pressure chronic ulcer of unspecified heel and midfoot with necrosis of bone

of 8 L97.409 Non-pressure chronic ulcer of unspecified heel and midfoot with unspecified severity L97.411 Non-pressure chronic ulcer of right heel and midfoot limited to breakdown of skin L97.412 Non-pressure chronic ulcer of right heel and midfoot with fat layer exposed L97.413 Non-pressure chronic ulcer of right heel and midfoot with necrosis of muscle L97.414 Non-pressure chronic ulcer of right heel and midfoot with necrosis of bone L97.419 Non-pressure chronic ulcer of right heel and midfoot with unspecified severity L97.421 Non-pressure chronic ulcer of left heel and midfoot limited to breakdown of skin L97.422 Non-pressure chronic ulcer of left heel and midfoot with fat layer exposed L97.423 Non-pressure chronic ulcer of left heel and midfoot with necrosis of muscle L97.424 Non-pressure chronic ulcer of left heel and midfoot with necrosis of bone L97.429 Non-pressure chronic ulcer of left heel and midfoot with unspecified severity L97.501 Non-pressure chronic ulcer of other part of unspecified foot limited to breakdown of skin L97.502 Non-pressure chronic ulcer of other part of unspecified foot with fat layer exposed L97.503 Non-pressure chronic ulcer of other part of unspecified foot with necrosis of muscle L97.504 Non-pressure chronic ulcer of other part of unspecified foot with necrosis of bone L97.509 Non-pressure chronic ulcer of other part of unspecified foot with unspecified severity L97.511 Non-pressure chronic ulcer of other part of right foot limited to breakdown of skin L97.512 Non-pressure chronic ulcer of other part of right foot with fat layer exposed L97.513 Non-pressure chronic ulcer of other part of right foot with necrosis of muscle L97.514 Non-pressure chronic ulcer of other part of right foot with necrosis of bone L97.519 Non-pressure chronic ulcer of other part of right foot with unspecified severity L97.521 Non-pressure chronic ulcer of other part of left foot limited to breakdown of skin L97.522 Non-pressure chronic ulcer of other part of left foot with fat layer exposed L97.523 Non-pressure chronic ulcer of other part of left foot with necrosis of muscle L97.524 Non-pressure chronic ulcer of other part of left foot with necrosis of bone L97.529 Non-pressure chronic ulcer of other part of left foot with unspecified severity L97.801 Non-pressure chronic ulcer of other part of unspecified lower leg limited to breakdown of skin L97.802 Non-pressure chronic ulcer of other part of unspecified lower leg with fat layer exposed L97.803 Non-pressure chronic ulcer of other part of unspecified lower leg with necrosis of muscle L97.804 Non-pressure chronic ulcer of other part of unspecified lower leg with necrosis of bone L97.809 Non-pressure chronic ulcer of other part of unspecified lower leg with unspecified severity L97.811 Non-pressure chronic ulcer of other part of right lower leg limited to breakdown of skin L97.812 Non-pressure chronic ulcer of other part of right lower leg with fat layer exposed L97.813 Non-pressure chronic ulcer of other part of right lower leg with necrosis of muscle L97.814 Non-pressure chronic ulcer of other part of right lower leg with necrosis of bone L97.819 Non-pressure chronic ulcer of other part of right lower leg with unspecified severity L97.821 Non-pressure chronic ulcer of other part of left lower leg limited to breakdown of skin L97.822 Non-pressure chronic ulcer of other part of left lower leg with fat layer exposed L97.823 Non-pressure chronic ulcer of other part of left lower leg with necrosis of muscle L97.824 Non-pressure chronic ulcer of other part of left lower leg with necrosis of bone L97.829 Non-pressure chronic ulcer of other part of left lower leg with unspecified severity L97.901 Non-pressure chronic ulcer of unspecified part of unspecified lower leg limited to breakdown of skin L97.902 Non-pressure chronic ulcer of unspecified part of unspecified lower leg with fat layer exposed L97.903 Non-pressure chronic ulcer of unspecified part of unspecified lower leg with necrosis of muscle

of 8 L97.904 Non-pressure chronic ulcer of unspecified part of unspecified lower leg with necrosis of bone L97.909 Non-pressure chronic ulcer of unspecified part of unspecified lower leg with unspecified severity L97.911 Non-pressure chronic ulcer of unspecified part of right lower leg limited to breakdown of skin L97.912 Non-pressure chronic ulcer of unspecified part of right lower leg with fat layer exposed L97.913 Non-pressure chronic ulcer of unspecified part of right lower leg with necrosis of muscle L97.914 Non-pressure chronic ulcer of unspecified part of right lower leg with necrosis of bone L97.919 Non-pressure chronic ulcer of unspecified part of right lower leg with unspecified severity L97.921 Non-pressure chronic ulcer of unspecified part of left lower leg limited to breakdown of skin L97.922 Non-pressure chronic ulcer of unspecified part of left lower leg with fat layer exposed L97.923 Non-pressure chronic ulcer of unspecified part of left lower leg with necrosis of muscle L97.924 Non-pressure chronic ulcer of unspecified part of left lower leg with necrosis of bone L97.929 Non-pressure chronic ulcer of unspecified part of left lower leg with unspecified severity L98.411 Non-pressure chronic ulcer of buttock limited to breakdown of skin L98.412 Non-pressure chronic ulcer of buttock with fat layer exposed L98.413 Non-pressure chronic ulcer of buttock with necrosis of muscle L98.414 Non-pressure chronic ulcer of buttock with necrosis of bone L98.419 Non-pressure chronic ulcer of buttock with unspecified severity L98.421 Non-pressure chronic ulcer of back limited to breakdown of skin L98.422 Non-pressure chronic ulcer of back with fat layer exposed L98.423 Non-pressure chronic ulcer of back with necrosis of muscle L98.424 Non-pressure chronic ulcer of back with necrosis of bone L98.429 Non-pressure chronic ulcer of back with unspecified severity L98.491 Non-pressure chronic ulcer of skin of other sites limited to breakdown of skin L98.492 Non-pressure chronic ulcer of skin of other sites with fat layer exposed L98.493 Non-pressure chronic ulcer of skin of other sites with necrosis of muscle L98.494 Non-pressure chronic ulcer of skin of other sites with necrosis of bone L98.499 Non-pressure chronic ulcer of skin of other sites with unspecified severity References New York State Medicaid Topical Oxygen Wound Therapy Guidelines. March 2008. Available at: http://www.emedny.org/providermanuals/dme/pdfs/2008-4_new%20york%20state%20medicaid%20topical%20oxygen%20wound%20therapy%20guidelines.pdf. Accessed September 15, 2015. Specialty-matched clinical peer review.